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FDA 510(k)

APR II NON-POROUS HIP STEM

K-Number: K913208 · 1991-10-11

ApplicantIntermedics Orthopedics
Decision Date1991-10-11
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APR II NON-POROUS HIP STEM is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics Orthopedics. It received FDA 510(k) clearance on 1991-10-11 under 510(k) number K913208. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APR II NON-POROUS HIP STEM?

APR II NON-POROUS HIP STEM is a medical device that received FDA 510(k) clearance on 1991-10-11. The listed applicant is Intermedics Orthopedics. The 510(k) number is K913208.

When did APR II NON-POROUS HIP STEM receive FDA 510(k) clearance?

APR II NON-POROUS HIP STEM received FDA 510(k) clearance on 1991-10-11, under 510(k) number K913208.

Who is the listed applicant for APR II NON-POROUS HIP STEM?

The FDA 510(k) record lists Intermedics Orthopedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APR II NON-POROUS HIP STEM?

The FDA product code for APR II NON-POROUS HIP STEM is JDI.

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Other records listing Intermedics Orthopedics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K970300NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTIK970498NATURAL-KNEE II REVISION FEMORAL SPACER LUGSK970166NATURAL-HIP SYSTEM COCR REVISION STEMK970567SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDSK964357NATURAL-HIP SYSTEM COCR STEMK964350MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA

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Related Devices (Code: JDI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer BiometK240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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